Device Classification Name |
dna-probe kit, human chromosome
|
510(k) Number |
K953591 |
Device Name |
CEP 8 SPECTRUMORANGE DNA PROBE KIT |
Applicant |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
RUSSELL K ENNS |
Correspondent |
VYSIS |
3100 WOODCREEK DR. |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
RUSSELL K ENNS |
Regulation Number | 866.4700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/01/1995 |
Decision Date | 11/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|